EDF files comments on three TSCA rules EPA is developing

Richard Denison, Ph.D., is a Lead Senior Scientist.

Yesterday was the deadline for stakeholders to file written comments on three rules EPA is now developing, as required under the new Toxic Substances Control Act (TSCA as amended by the Lautenberg Act).  EPA is moving quickly to get input on these rules, which it intends to propose in December in order to stay on track to finalize the rules by June of next year, as mandated under the new law.

The solicitation of written comments follows public meetings EPA held on August 9, 10 and 11 to get input from stakeholders on these rules, at which dozens of stakeholders provided oral comments.  Those meetings were the first EPA public meetings since the Lautenberg Act was signed into law on June 22.

The three rules (and associated docket numbers) on which EPA solicited comments are:

  • Risk-Based Prioritization Procedural Rule, which will set forth the process and criteria EPA will use to prioritize chemicals in commerce. Docket EPA-HQ-OPPT-2016-0399
  • Risk Evaluation Procedural Rule, which will set forth the process EPA will use to conduct risk evaluations of high-priority and industry-requested chemicals. Docket EPA-HQ-OPPT-2016-0400
  • Rule Establishing Fees for the Administration of TSCA, which will detail how EPA will collect fees from companies to defray the costs of administering core activities under the new law. Docket EPA-HQ-OPPT-2016-0401

EDF filed comments yesterday on all three rules, available here, here and here.

Several of the key recommendations from each of our comments follow.  


  1. The prioritization rule should be procedural in nature, and the specifics of science policy issues should be left to guidance documents and policy statements.
  2. The process established by the prioritization rule should include concrete steps to collect and develop information on chemicals that lack sufficient data on which to base prioritization decisions.
  3. Close coordination between the prioritization and risk evaluation processes is needed to ensure deadlines are consistently met.
  4. EPA prioritization decisions must apply to chemicals, not to particular uses or conditions of use.
  5. A wide range of types of data should be able to be used to identify high-priority chemicals.
  6. More robust and complete data are needed for low-priority designations than for high-priority designations.

Risk Evaluation

  1. The risk evaluation rule should be procedural in nature, and the specifics of science policy issues should be left to guidance documents and policy statements.
  2. The risk evaluation rule should further delineate the definitions of “intended, known, or reasonably foreseen” conditions of use and “potentially exposed or susceptible subpopulations.”
  3. In establishing the scope of a risk evaluation, EPA should
    • provide a public comment opportunity; and
    • consider all uses of a chemical and all potentially relevant subpopulations, but have authority to choose a scope that is narrower where fully justified.
  1. For uses and conditions of use included in the scope of a risk evaluation, EPA should generally assess exposure on an aggregate basis.
  2. Any draft risk evaluations submitted by interested persons need to be subject to public comment, and should not determine or limit the scope of EPA’s risk evaluation.
  3. The scope of industry-requested risk evaluations should be established by EPA, not the manufacturer requesting the risk evaluation.
  4. Peer reviews of EPA risk evaluations need to use procedures to ensure reviewers do not have conflicts of interest.


  1. EPA should assess fees in direct proportion to the level of effort the Agency will expend on the particular activity to which a fee applies. EPA should not exempt from fees certain EPA reviews or other activities that will require resources to conduct and that fall under areas of the law that are squarely within its fee authority.
  2. All of the costs to EPA associated with its reviews and other activities need to be included in the baseline budget on the basis of which the overall level of fees is to be determined.
  3. The level of fees required of a manufacturer requesting a risk evaluation must reflect EPA’s costs for the full risk evaluation EPA conducts.
  4. EPA should not initiate industry-requested risk evaluations until it has received the applicable fees mandated to defray its costs.
  5. Companies should not be allowed to pay a higher fee in order to expedite EPA’s review of its new or existing chemical.



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